1. Field of the Invention
The present invention relates to a device for the treatment of morbid obesity, and in particular, it relates to gastric banding devices that encircle a portion of the stomach to form a stoma opening of lesser diameter.
2. Description of the Prior Art
Morbid obesity is a condition that is associated with a multitude of other hazards to health that include reduced life expectancy and has even been associated with serious sociopsychologic and economic problems. Dietary management of morbid obesity has not been a successful manner of treatment. In response to the failure of dietary management, various surgical techniques have been developed and used to try to treat morbid obesity.
One method that has been used in the prior art to treat morbid obesity has been referred to as a gastric bypass. The term gastric bypass has been used to describe several different procedures. Some of these procedures are described in articles by Joffe et al, "A Review: Surgery for Morbid Obesity," Jour. Surg. Sci., Vol. 33, pp. 74-88, 1982; Mason et al, "Optimizing Results of Gastric Bypass," Ann. Surg., Vol. 182, No. 4, pp. 405-414, October 1975; and Mason et al, "Risk Reduction in Gastric Operations for Obesity," Ann. Surg., Vol. 190, No. 2, pp. 158-165, August 1979. Gastric bypass has been considered by some as a procedure having considerable risks.
Stapling of portions of the stomach has also been used to treat morbid obesity. This includes both vertical and horizontal stapling and other variations trying to reduce the size of the stomach or make a small stoma opening. Stapling has been described by Freeman et al, "Surgery for Morbid Obesity--Where Are We Going?" The Canadian Journal of Surgery, Vol. 25, No. 3, pp. 247-248, May 1982; Freeman et al, "Failure Rate with Gastric Partitioning for Morbid Obesity," The American Journal of Surgery, Vol. 145, pp. 113-119, January 1983; Reed, "Bad and Good News on Gastroplasty," Journal of the American Medical Association, Medical News, Vol. 248, No. 3, pp. 277-278, July 16, 1982; Mason et al, "Risk Reduction in Gastric Operations for Obesity," Ann. Surg., Vol. 190, No. 2, pp. 158-165, August 1979; and Mason, "Vertical Banded Gastroplasty for Obesity," Arch. Surg., Vol. 117, pp. 701-706, May 1982. Many problems have been associated with the use of staples, first as being undependable, second as causing perforations, and third that the pouch or stoma opening formed by the staples becomes enlarged over time making the procedure useless.
Another method that has been developed is the placement of an inflatable bag or balloon into the stomach causing the recipient a "full feeling." This procedure has been described in the Berman et al U.S. Pat. No. 4,133,315 and the Foster, Jr. U.S. Pat. No. 4,485,805. This procedure, although simple, can also result in the stomach further expanding and making the placement of the bag useless.
Still another procedure includes the placement of a sleeve or a wrap on the inside of the stomach or covering the stomach in the outside. The Rockey U.S. Pat. No. 4,501,264 describes a medical sleeve that is placed on the inside of the stomach which interferes with the digestive or absorption function of the zone in which the sleeve is placed. The wrap which is placed around the stomach is described in the Wilkinson et al U.S. Pat. No. 4,403,604 and in an article by Wilkinson entitled "Gastric (Reservoir) Reduction for Morbid Obesity," Arch. Surg., Vol. 116, pp. 602-605, May 1981.
Still another method includes the placement of a band around a portion of the stomach creating a stoma opening that is less in diameter than the stomach for restricting food intake into the lower digestive portion of the stomach. The band is made of a nonextensible material and is located on the outside of the stomach thereby prohibiting the stoma opening to expand. This banding procedure has been described in articles by Solhaug, "Gastric Banding: A New Method in the Treatment of Morbid Obesity," Current Surgery, pp. 424-428, November--December 1983; and Check, "Yet Another Variation on Surgery for Obesity," Journal of the American Medical Association, Vol. 248, No. 16, pp. 1939, 1943, Oct. 22/29, 1982. Although the banding procedure has great promise due to its simplicity and the fact that it retains the diameter of the stoma opening, there have been problems in obtaining a proper size stoma opening.